In the field of formulations, various software tools are commonly used to streamline and optimize the development process. One such software is formulation management software, which helps in creating and managing formulations by allowing scientists to input ingredient quantities, calculate costs, and analyze ingredient interactions. Additionally, simulation software like computational fluid dynamics (CFD) programs are utilized to model and predict how formulations will behave under different conditions, aiding in the design of efficient manufacturing processes. Furthermore, statistical analysis software plays a crucial role in analyzing experimental data and optimizing formulations based on statistical models, ensuring that the final product meets desired specifications. Overall, these software tools enhance productivity, accuracy, and efficiency in the formulation development workflow.
Software Used In Formulation Design Process (Pharmaceutics).PdfRAHUL PAL
This is an Minor project of mine, to explaining the Various software which are generally used in the designing for drug dosage form .
This project gave me more of the knowledge about drug designing.
In which lots of software are considered as Formulation.
Helping for PHARMACEUTICS, PHARMACEUTICAL ANALYSIS student. And some of articles review.
It's data are from standard as well as notebook.
This document discusses achieving desired productivity through effective production gap analysis. It defines production gap analysis as identifying gaps between optimized resource allocation/integration of inputs and current performance levels. Once industry expectations are understood, a company's performance can be compared to identify gaps, which can be analyzed at strategic, tactical or operational levels. The author conducted gap analysis at a pharmaceutical company to identify reasons for production shortfalls and make recommendations to improve productivity.
This document is a project report submitted by Roshanjit Kar Bhowmik for the partial fulfillment of a Bachelor of Business Management degree. The project analyzes consumer perception towards preventive healthcare in order to drive marketing programs for Asha Biometric Services Pvt. Ltd. It begins with an introduction to the healthcare industry and preventive healthcare. It then discusses the research design, company profile, data analysis and interpretation, findings, conclusions, and recommendations.
A review article on visual inspection program for sterile injectable product ...Palash Das
This document provides an overview of the manual visual inspection process for sterile injectable products. It discusses the risks of particulate contamination throughout the manufacturing process and identifies potential sources such as environment, materials, equipment, utilities and methods. The document outlines the typical manufacturing process flow and emphasizes the importance of controlling the aseptic process through measures like qualified equipment and facilities, validated processes, and trained personnel. It examines the key aspects of developing an inspection program including inspector qualification, process establishment, and regulatory expectations around ensuring products are free of visible defects.
This document provides an overview of Nutramedica Laboratories Sdn Bhd (NLSB), including its services, product development process, standard operating procedures, and regulatory requirements. NLSB is a GMP-certified manufacturer of herbal and plant-based personal care and health supplements. It assists clients with product formulation, certification, and testing. The document outlines the roles and responsibilities of NLSB's R&D staff and lab assistants. It also includes a list of services provided and pricing, as well as charts detailing the business and product development flows.
This document provides an executive summary and career profile for Dr. B. Guruswamy, who has over 17 years of experience in API research, process development, scale up, and life cycle management in the pharmaceutical industry. He is currently a Senior Principal Scientist at Neuland Laboratories in Hyderabad, India, where he leads a team of 20 scientists in multiple projects related to API synthesis and process optimization. The summary highlights his educational background, roles and responsibilities, career achievements, areas of expertise, publications, patents, and research experience.
The document discusses the importance of drug formulation in pharmaceutical development. It states that drug formulation involves combining active drugs with other substances to create safe and effective products for human consumption. However, formulation is often overlooked in early drug development stages. This can lead to costly delays if not addressed. The document recommends adopting an integrated approach where formulation is considered throughout development. Formulations should be tailored to each study phase and developed with a comprehensive understanding of the drug's properties. With open communication across teams and formulation as an integral part of development, companies can reduce risks and costs and get products to patients more efficiently.
Software Used In Formulation Design Process (Pharmaceutics).PdfRAHUL PAL
This is an Minor project of mine, to explaining the Various software which are generally used in the designing for drug dosage form .
This project gave me more of the knowledge about drug designing.
In which lots of software are considered as Formulation.
Helping for PHARMACEUTICS, PHARMACEUTICAL ANALYSIS student. And some of articles review.
It's data are from standard as well as notebook.
This document discusses achieving desired productivity through effective production gap analysis. It defines production gap analysis as identifying gaps between optimized resource allocation/integration of inputs and current performance levels. Once industry expectations are understood, a company's performance can be compared to identify gaps, which can be analyzed at strategic, tactical or operational levels. The author conducted gap analysis at a pharmaceutical company to identify reasons for production shortfalls and make recommendations to improve productivity.
This document is a project report submitted by Roshanjit Kar Bhowmik for the partial fulfillment of a Bachelor of Business Management degree. The project analyzes consumer perception towards preventive healthcare in order to drive marketing programs for Asha Biometric Services Pvt. Ltd. It begins with an introduction to the healthcare industry and preventive healthcare. It then discusses the research design, company profile, data analysis and interpretation, findings, conclusions, and recommendations.
A review article on visual inspection program for sterile injectable product ...Palash Das
This document provides an overview of the manual visual inspection process for sterile injectable products. It discusses the risks of particulate contamination throughout the manufacturing process and identifies potential sources such as environment, materials, equipment, utilities and methods. The document outlines the typical manufacturing process flow and emphasizes the importance of controlling the aseptic process through measures like qualified equipment and facilities, validated processes, and trained personnel. It examines the key aspects of developing an inspection program including inspector qualification, process establishment, and regulatory expectations around ensuring products are free of visible defects.
This document provides an overview of Nutramedica Laboratories Sdn Bhd (NLSB), including its services, product development process, standard operating procedures, and regulatory requirements. NLSB is a GMP-certified manufacturer of herbal and plant-based personal care and health supplements. It assists clients with product formulation, certification, and testing. The document outlines the roles and responsibilities of NLSB's R&D staff and lab assistants. It also includes a list of services provided and pricing, as well as charts detailing the business and product development flows.
This document provides an executive summary and career profile for Dr. B. Guruswamy, who has over 17 years of experience in API research, process development, scale up, and life cycle management in the pharmaceutical industry. He is currently a Senior Principal Scientist at Neuland Laboratories in Hyderabad, India, where he leads a team of 20 scientists in multiple projects related to API synthesis and process optimization. The summary highlights his educational background, roles and responsibilities, career achievements, areas of expertise, publications, patents, and research experience.
The document discusses the importance of drug formulation in pharmaceutical development. It states that drug formulation involves combining active drugs with other substances to create safe and effective products for human consumption. However, formulation is often overlooked in early drug development stages. This can lead to costly delays if not addressed. The document recommends adopting an integrated approach where formulation is considered throughout development. Formulations should be tailored to each study phase and developed with a comprehensive understanding of the drug's properties. With open communication across teams and formulation as an integral part of development, companies can reduce risks and costs and get products to patients more efficiently.
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...Marcep Inc.
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
Dr. Krunal M. Patel has over 1 year of experience as a research associate in pharmacovigilance. He currently works at Lambda Therapeutic Research Limited in Ahmedabad, where his responsibilities include quality review of ICSRs, regulatory submissions, case processing, and preparation/revision of SOPs and training documents. He has a PhD in Pharmaceutical Sciences from Jodhpur National University and expertise in pharmacovigilance, regulatory affairs, and quality systems.
Dr. Krunal M. Patel has over 1 year of experience as a research associate in pharmacovigilance. He currently works at Lambda Therapeutic Research Limited in Ahmedabad, where his responsibilities include quality review of ICSRs, regulatory submissions, case processing, and preparation/revision of SOPs and training documents. He has a PhD in Pharmaceutical Sciences from Jodhpur National University and expertise in pharmacovigilance, regulatory affairs, and quality systems.
Dr. Krunal M. Patel has over 1 year of experience as a research associate in pharmacovigilance. He currently works at Lambda Therapeutic Research Limited in Ahmedabad, where his responsibilities include quality review of ICSRs, regulatory submissions, case processing, and preparation/revision of SOPs and training documents. He has a PhD in Pharmaceutical Sciences from Jodhpur National University and expertise in pharmacovigilance, regulatory affairs, and quality systems.
Gampa Srinivas is seeking a position in formulation research and development with a leading pharmaceutical company. He has over 1.8 years of experience in R&D formulation at Leiutis Pharmaceuticals. His experience includes formulation development of injectables, depot formulations, lyophilized products, and more. He is proficient in quality by design, pharmacokinetics, and using software like WinNonlin. He holds an M.Pharm from NIPER Raebareli and a B.Pharm from Nalanda College of Pharmacy.
1) Ruturaj K Sutarsandhiya is seeking a challenging opportunity in pharmaceutical analytical development with a focus on method development, validation, and stability studies.
2) He has over 15 years of experience in method development, validation, and stability studies for drug products and substances. He has experience conducting in vitro bioequivalence studies.
3) His most recent role was as Manager I at Sun Pharmaceuticals, where he successfully completed over 150 method validations and was a key member of the organization.
Mahesh V. Shingala is seeking a challenging position in the pharmaceutical industry where he can foster innovation. He has over 7 years of experience in formulation and development of oral tablets and injections at Apothecon Pharmaceutical and Unimark Remedies. His responsibilities included new product development, coordination with regulatory departments, and preparation of development documents. He has a M.Pharm and B.Pharm degree and is GATE qualified. He is proficient in MS Office and interested in regulatory market product development.
Change thesis: how to introduce and manage organize changerangada shah
One of the most baffling issues which business executives face is an employee’s degree of resistance and adaptation to change. This is a difficult time for global pharmaceutical
companies — the unending series of concerns that pharmaceutical companies face include payers tightening up on cost management, strained government healthcare budgets, the need to understand and adopt new technologies, and challenges to their traditional pricing mechanisms
by empowered stakeholders, from patients to payers. Thus in this hustle and bustle and matching global cut-throat competition, human capital becomes the victim of change where sometimes they adopt changes and sometimes resist.
In Silico Pharmacology for Drug Discovery_ A systematic review on commonly u...NoumanMomin1
This document discusses in silico pharmacology and commonly used software for drug discovery. It defines in silico pharmacology as using computational models for simulations to make predictions and advances in medicines. The objectives of in silico methods are to identify mechanisms of action, predict drug properties, develop models for biological response, speed up and reduce costs of discovery. Commonly used software like GOLD, SANJEEVINI, GASTROPLUS, and DDD PLUS are used for tasks like protein-ligand docking, predicting binding affinity, ADME prediction, and dissolution experiments. In conclusion, software approaches are playing a major role in drug design and discovery by facilitating pharmacokinetics/dynamics studies.
Pradeep Sarda is seeking assignments in pharmaceutical formulation development. He has over 10 years of experience in formulation and development of various dosage forms including tablets, capsules, and modified release formulations. He has worked at several companies, including IPCA Indore, Famycare Ahmadabad, and Mylan Laboratories. His experience includes preformulation studies, process development, scale-up, technology transfer, and generating documentation for product development and regulatory submissions. He has expertise in pelletization, granulation, compression, and coating processes. Pradeep holds an MPharm in Pharmaceutics and has handled various projects involving formulation of anti-malarial, contraceptive, and anti-Parkinson drugs.
Dhananjay Deshmukh is seeking a new position and provides a summary of his relevant experience and qualifications. He currently works as a senior research officer at Serum Institute of India in Pune with over 6 years of experience in research and development. His experience includes product development, purification of bacterial vaccines and biosimilars, process characterization and validation. He has a M.Sc. in Biotechnology and is pursuing an MBA with a specialization in operations management. He is organized, results-oriented and has experience leading projects and working in a team environment.
Guidelines on Virtuous Pharmacovigilance Practices | Pepgra HealthcarePEPGRA Healthcare
This document outlines guidelines for virtuous pharmacovigilance practices as presented by Dr. Nancy Agnes of Pepgra Group. It discusses the need to protect patients and public health through pharmacovigilance. The introduction describes pharmacovigilance systems and their responsibility for drug safety authorization. Key principles for guidelines include meeting patient and public needs, providing Good Pharmacovigilance Practice guidelines, and continuous quality improvement. Responsibilities of pharmacovigilance organizations include ensuring qualified staff, adequate resources, and a systematic approach to quality.
0601017 explore market opportunities for new product launchSupa Buoy
Hi Friends
This is supa bouy
I am a mentor, Friend for all Management Aspirants, Any query related to anything in Management, Do write me @ supabuoy@gmail.com.
I will try to assist the best way I can.
Cheers to lyf…!!!
Supa Bouy
Running Head MEDICAL NEEDS 1MEDICAL NEEDS 4.docxtodd581
Running Head: MEDICAL NEEDS 1
MEDICAL NEEDS 4
MEDICAL NEEDS
Institution Affiliation
Student Name
Date
There are eight important dimensional qualities that can serve a huge part in the development of a business. Some of these dimensions are equally reinforcing and push business to do better and move to the next level. However, product service or good can rank high in one of the dimensions and rank low in another dimension. For medical Needs business to give better results they should focus on building in these dimensions, (Chvala & Johnson, 2017).
Performance: Medical Needs should ensure that they provide all the medical devices that the doctors prescribe to any patient. They should plan in such a way that all products are available in the required time.
Features: Medical Needs should have products or services that supplement their core functioning. Medical Needs can provide a free weighing machine and free BMI testing.
Reliability: Medical Needs should work on providing products on the stipulated time and the right quantities, with this, they will receive the benefit of reliability which every customer is looking for.
Conformity: Just as Medical needs stated regarding a provision of vendors in all areas and ensuring that all medical products are available to the patients, they should focus mainly on that.
Durability: Medical Needs should focus mainly on providing durable products and services. They should try not to fail customers at any point, (Garvin, 1987).
Serviceability: This business should mainly focus on the needs of the customers. They should offer fast services, courteous services, competent work, and original medical products.
Aesthetics: The outlook of each product is so important, so it is very important for Medical Needs to ensure that their products have a better outlook and an attractive customer service.
Perception: Customer’s perception is crucial for any business. Medical Needs should listen to their customer’s plea and perception towards their services and work towards bettering the services according to the customer’s perception, (Ross, 2017).
To achieve quality gains, the managers need to perceive things in a different outlook. For any upcoming business, it will be necessary to perform these eight dimensions to ensure that their business picks up and moves to the next level. Medical Needs have a classified goal which is going to be achieved along implementation of the eight-dimensional model.
References
Chvala, R. J., & Johnson, W. C. (2017). Why Total Quality in Marketing. In Total Quality in Marketing (pp. 1-26). Routledge.
Garvin, D. (1987). Competing on the eight dimensions of quality. Harv. Bus. Rev., 101-109.
Ross, J. E. (2017). Total quality management: Text, cases, and readings. Routledge.
Medical Needs Quality Assurance Integration
Connie Farris
Colorado Technical University
Project Performance and Quality Assurance
(MPM357-1902A-02)
Jason Lewis
Running he.
Running Head MEDICAL NEEDS 1MEDICAL NEEDS 4.docxglendar3
Running Head: MEDICAL NEEDS 1
MEDICAL NEEDS 4
MEDICAL NEEDS
Institution Affiliation
Student Name
Date
There are eight important dimensional qualities that can serve a huge part in the development of a business. Some of these dimensions are equally reinforcing and push business to do better and move to the next level. However, product service or good can rank high in one of the dimensions and rank low in another dimension. For medical Needs business to give better results they should focus on building in these dimensions, (Chvala & Johnson, 2017).
Performance: Medical Needs should ensure that they provide all the medical devices that the doctors prescribe to any patient. They should plan in such a way that all products are available in the required time.
Features: Medical Needs should have products or services that supplement their core functioning. Medical Needs can provide a free weighing machine and free BMI testing.
Reliability: Medical Needs should work on providing products on the stipulated time and the right quantities, with this, they will receive the benefit of reliability which every customer is looking for.
Conformity: Just as Medical needs stated regarding a provision of vendors in all areas and ensuring that all medical products are available to the patients, they should focus mainly on that.
Durability: Medical Needs should focus mainly on providing durable products and services. They should try not to fail customers at any point, (Garvin, 1987).
Serviceability: This business should mainly focus on the needs of the customers. They should offer fast services, courteous services, competent work, and original medical products.
Aesthetics: The outlook of each product is so important, so it is very important for Medical Needs to ensure that their products have a better outlook and an attractive customer service.
Perception: Customer’s perception is crucial for any business. Medical Needs should listen to their customer’s plea and perception towards their services and work towards bettering the services according to the customer’s perception, (Ross, 2017).
To achieve quality gains, the managers need to perceive things in a different outlook. For any upcoming business, it will be necessary to perform these eight dimensions to ensure that their business picks up and moves to the next level. Medical Needs have a classified goal which is going to be achieved along implementation of the eight-dimensional model.
References
Chvala, R. J., & Johnson, W. C. (2017). Why Total Quality in Marketing. In Total Quality in Marketing (pp. 1-26). Routledge.
Garvin, D. (1987). Competing on the eight dimensions of quality. Harv. Bus. Rev., 101-109.
Ross, J. E. (2017). Total quality management: Text, cases, and readings. Routledge.
Medical Needs Quality Assurance Integration
Connie Farris
Colorado Technical University
Project Performance and Quality Assurance
(MPM357-1902A-02)
Jason Lewis
Running he.
0601017 explore market opportunities for new product launchSupa Buoy
This document is a project report submitted by Dnyanesh Prabhakar Joshi to the University of Pune in partial fulfillment of an MBA degree. The project involved exploring market opportunities for a new product launch by Resilient Cosmeceuticals Pvt. Ltd. in Pune, India. Joshi conducted primary research including surveys of doctors and chemists in Pune to analyze the market for anti-ulcer and anti-emetic drugs, and provide suggestions to Resilient Cosmeceuticals. The report includes an executive summary of the company, industry, and product being launched, as well as chapters describing the research methodology, findings of the surveys, and recommendations.
Shivaan Cooppan is a Production Pharmacist at Ranbaxy-Be-Tabs in Johannesburg, South Africa. He has held this position since July 2012, where he oversees the manufacturing of medications. Some of his accomplishments include successfully auditing for GMP compliance from 2012-2014, creating standard operating procedures and tracking systems, and reducing rejected batches due to process errors. Prior to his current role, Cooppan worked as a Community Service Pharmacist from June 2011-June 2012 and did a pharmacy internship from October 2010-January 2011 to complete his education and training.
This document provides a summary of the professional experience and qualifications of Dhiraj Kumar Chopra. It outlines his 20+ years of experience in the pharmaceutical industry, particularly in generic product development, parenteral formulations, and novel drug delivery systems. It also lists his employment history and achievements, as well as his education qualifications and publications.
Kanuri Prasad is seeking a career in quality assurance and regulatory affairs in the pharmaceutical manufacturing industry. He has over 4 years of experience in quality assurance at Vasudha Pharma Chem Limited, where he currently holds the role of Executive in the Corporate Quality Assurance department. His responsibilities include vendor qualification, change control reviews, complaint investigations, and preparation of regulatory documents like Drug Master Files. He holds a B.Pharmacy degree and has experience in process validation, cleaning validation, and internal auditing.
Major Project (B. Pharm) OPIUM POPPY PROJECT.pdfRAHUL PAL
Opium cultivation, an ancient practice rooted in regions like the Golden Triangle and Golden Crescent, involves a meticulous process blending nature and human intervention. Picture a serene landscape with gently rolling hills blanketed in lush greenery. Amidst this verdant tapestry stand tall, slender opium poppy plants, their delicate petals shimmering in hues of pink and white. These plants exude an air of mystique, their bulbous seed pods containing the coveted opium latex. Skilled farmers nurture these plants with utmost care, tending to their needs for water, nutrients, and protection from pests. The cultivation cycle begins with sowing the poppy seeds during specific seasons conducive to their growth. As the plants mature, they blossom into exquisite flowers, each harboring the potential for opium production. The farmers deftly slit the seed pods at just the right moment, allowing the milky sap to seep out and gradually solidify into opium. This labor-intensive process demands precision and patience, as any misstep can impact the potency and quality of the opium yield. Despite its allure, opium cultivation is not without controversy and challenges. Legal restrictions, environmental concerns, and the socioeconomic impacts on communities underscore the complex nature of this age-old practice. However, for those entrenched in the art of opium cultivation, it remains a delicate dance between tradition, livelihood, and the ever-evolving dynamics of global demand and supply.
Niosomes are nanosized vesicles composed of nonionic surfactants and cholesterol that form when these compounds are dispersed in an aqueous medium. These lipid-based structures are similar to liposomes but differ in their composition, as niosomes use nonionic surfactants instead of phospholipids. The unique characteristic of niosomes lies in their ability to encapsulate both hydrophilic and hydrophobic drugs within their bilayer membrane. This feature makes them promising candidates for drug delivery systems, as they can protect the encapsulated drug from degradation, prolong its release, and enhance its bioavailability. Additionally, niosomes offer advantages such as biocompatibility, stability, and ease of preparation, making them a versatile platform for targeted drug delivery and other biomedical applications.
Más contenido relacionado
Similar a Software Used In Formulation Design Process- Minor Project [Bachelor].pdf
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...Marcep Inc.
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
Dr. Krunal M. Patel has over 1 year of experience as a research associate in pharmacovigilance. He currently works at Lambda Therapeutic Research Limited in Ahmedabad, where his responsibilities include quality review of ICSRs, regulatory submissions, case processing, and preparation/revision of SOPs and training documents. He has a PhD in Pharmaceutical Sciences from Jodhpur National University and expertise in pharmacovigilance, regulatory affairs, and quality systems.
Dr. Krunal M. Patel has over 1 year of experience as a research associate in pharmacovigilance. He currently works at Lambda Therapeutic Research Limited in Ahmedabad, where his responsibilities include quality review of ICSRs, regulatory submissions, case processing, and preparation/revision of SOPs and training documents. He has a PhD in Pharmaceutical Sciences from Jodhpur National University and expertise in pharmacovigilance, regulatory affairs, and quality systems.
Dr. Krunal M. Patel has over 1 year of experience as a research associate in pharmacovigilance. He currently works at Lambda Therapeutic Research Limited in Ahmedabad, where his responsibilities include quality review of ICSRs, regulatory submissions, case processing, and preparation/revision of SOPs and training documents. He has a PhD in Pharmaceutical Sciences from Jodhpur National University and expertise in pharmacovigilance, regulatory affairs, and quality systems.
Gampa Srinivas is seeking a position in formulation research and development with a leading pharmaceutical company. He has over 1.8 years of experience in R&D formulation at Leiutis Pharmaceuticals. His experience includes formulation development of injectables, depot formulations, lyophilized products, and more. He is proficient in quality by design, pharmacokinetics, and using software like WinNonlin. He holds an M.Pharm from NIPER Raebareli and a B.Pharm from Nalanda College of Pharmacy.
1) Ruturaj K Sutarsandhiya is seeking a challenging opportunity in pharmaceutical analytical development with a focus on method development, validation, and stability studies.
2) He has over 15 years of experience in method development, validation, and stability studies for drug products and substances. He has experience conducting in vitro bioequivalence studies.
3) His most recent role was as Manager I at Sun Pharmaceuticals, where he successfully completed over 150 method validations and was a key member of the organization.
Mahesh V. Shingala is seeking a challenging position in the pharmaceutical industry where he can foster innovation. He has over 7 years of experience in formulation and development of oral tablets and injections at Apothecon Pharmaceutical and Unimark Remedies. His responsibilities included new product development, coordination with regulatory departments, and preparation of development documents. He has a M.Pharm and B.Pharm degree and is GATE qualified. He is proficient in MS Office and interested in regulatory market product development.
Change thesis: how to introduce and manage organize changerangada shah
One of the most baffling issues which business executives face is an employee’s degree of resistance and adaptation to change. This is a difficult time for global pharmaceutical
companies — the unending series of concerns that pharmaceutical companies face include payers tightening up on cost management, strained government healthcare budgets, the need to understand and adopt new technologies, and challenges to their traditional pricing mechanisms
by empowered stakeholders, from patients to payers. Thus in this hustle and bustle and matching global cut-throat competition, human capital becomes the victim of change where sometimes they adopt changes and sometimes resist.
In Silico Pharmacology for Drug Discovery_ A systematic review on commonly u...NoumanMomin1
This document discusses in silico pharmacology and commonly used software for drug discovery. It defines in silico pharmacology as using computational models for simulations to make predictions and advances in medicines. The objectives of in silico methods are to identify mechanisms of action, predict drug properties, develop models for biological response, speed up and reduce costs of discovery. Commonly used software like GOLD, SANJEEVINI, GASTROPLUS, and DDD PLUS are used for tasks like protein-ligand docking, predicting binding affinity, ADME prediction, and dissolution experiments. In conclusion, software approaches are playing a major role in drug design and discovery by facilitating pharmacokinetics/dynamics studies.
Pradeep Sarda is seeking assignments in pharmaceutical formulation development. He has over 10 years of experience in formulation and development of various dosage forms including tablets, capsules, and modified release formulations. He has worked at several companies, including IPCA Indore, Famycare Ahmadabad, and Mylan Laboratories. His experience includes preformulation studies, process development, scale-up, technology transfer, and generating documentation for product development and regulatory submissions. He has expertise in pelletization, granulation, compression, and coating processes. Pradeep holds an MPharm in Pharmaceutics and has handled various projects involving formulation of anti-malarial, contraceptive, and anti-Parkinson drugs.
Dhananjay Deshmukh is seeking a new position and provides a summary of his relevant experience and qualifications. He currently works as a senior research officer at Serum Institute of India in Pune with over 6 years of experience in research and development. His experience includes product development, purification of bacterial vaccines and biosimilars, process characterization and validation. He has a M.Sc. in Biotechnology and is pursuing an MBA with a specialization in operations management. He is organized, results-oriented and has experience leading projects and working in a team environment.
Guidelines on Virtuous Pharmacovigilance Practices | Pepgra HealthcarePEPGRA Healthcare
This document outlines guidelines for virtuous pharmacovigilance practices as presented by Dr. Nancy Agnes of Pepgra Group. It discusses the need to protect patients and public health through pharmacovigilance. The introduction describes pharmacovigilance systems and their responsibility for drug safety authorization. Key principles for guidelines include meeting patient and public needs, providing Good Pharmacovigilance Practice guidelines, and continuous quality improvement. Responsibilities of pharmacovigilance organizations include ensuring qualified staff, adequate resources, and a systematic approach to quality.
0601017 explore market opportunities for new product launchSupa Buoy
Hi Friends
This is supa bouy
I am a mentor, Friend for all Management Aspirants, Any query related to anything in Management, Do write me @ supabuoy@gmail.com.
I will try to assist the best way I can.
Cheers to lyf…!!!
Supa Bouy
Running Head MEDICAL NEEDS 1MEDICAL NEEDS 4.docxtodd581
Running Head: MEDICAL NEEDS 1
MEDICAL NEEDS 4
MEDICAL NEEDS
Institution Affiliation
Student Name
Date
There are eight important dimensional qualities that can serve a huge part in the development of a business. Some of these dimensions are equally reinforcing and push business to do better and move to the next level. However, product service or good can rank high in one of the dimensions and rank low in another dimension. For medical Needs business to give better results they should focus on building in these dimensions, (Chvala & Johnson, 2017).
Performance: Medical Needs should ensure that they provide all the medical devices that the doctors prescribe to any patient. They should plan in such a way that all products are available in the required time.
Features: Medical Needs should have products or services that supplement their core functioning. Medical Needs can provide a free weighing machine and free BMI testing.
Reliability: Medical Needs should work on providing products on the stipulated time and the right quantities, with this, they will receive the benefit of reliability which every customer is looking for.
Conformity: Just as Medical needs stated regarding a provision of vendors in all areas and ensuring that all medical products are available to the patients, they should focus mainly on that.
Durability: Medical Needs should focus mainly on providing durable products and services. They should try not to fail customers at any point, (Garvin, 1987).
Serviceability: This business should mainly focus on the needs of the customers. They should offer fast services, courteous services, competent work, and original medical products.
Aesthetics: The outlook of each product is so important, so it is very important for Medical Needs to ensure that their products have a better outlook and an attractive customer service.
Perception: Customer’s perception is crucial for any business. Medical Needs should listen to their customer’s plea and perception towards their services and work towards bettering the services according to the customer’s perception, (Ross, 2017).
To achieve quality gains, the managers need to perceive things in a different outlook. For any upcoming business, it will be necessary to perform these eight dimensions to ensure that their business picks up and moves to the next level. Medical Needs have a classified goal which is going to be achieved along implementation of the eight-dimensional model.
References
Chvala, R. J., & Johnson, W. C. (2017). Why Total Quality in Marketing. In Total Quality in Marketing (pp. 1-26). Routledge.
Garvin, D. (1987). Competing on the eight dimensions of quality. Harv. Bus. Rev., 101-109.
Ross, J. E. (2017). Total quality management: Text, cases, and readings. Routledge.
Medical Needs Quality Assurance Integration
Connie Farris
Colorado Technical University
Project Performance and Quality Assurance
(MPM357-1902A-02)
Jason Lewis
Running he.
Running Head MEDICAL NEEDS 1MEDICAL NEEDS 4.docxglendar3
Running Head: MEDICAL NEEDS 1
MEDICAL NEEDS 4
MEDICAL NEEDS
Institution Affiliation
Student Name
Date
There are eight important dimensional qualities that can serve a huge part in the development of a business. Some of these dimensions are equally reinforcing and push business to do better and move to the next level. However, product service or good can rank high in one of the dimensions and rank low in another dimension. For medical Needs business to give better results they should focus on building in these dimensions, (Chvala & Johnson, 2017).
Performance: Medical Needs should ensure that they provide all the medical devices that the doctors prescribe to any patient. They should plan in such a way that all products are available in the required time.
Features: Medical Needs should have products or services that supplement their core functioning. Medical Needs can provide a free weighing machine and free BMI testing.
Reliability: Medical Needs should work on providing products on the stipulated time and the right quantities, with this, they will receive the benefit of reliability which every customer is looking for.
Conformity: Just as Medical needs stated regarding a provision of vendors in all areas and ensuring that all medical products are available to the patients, they should focus mainly on that.
Durability: Medical Needs should focus mainly on providing durable products and services. They should try not to fail customers at any point, (Garvin, 1987).
Serviceability: This business should mainly focus on the needs of the customers. They should offer fast services, courteous services, competent work, and original medical products.
Aesthetics: The outlook of each product is so important, so it is very important for Medical Needs to ensure that their products have a better outlook and an attractive customer service.
Perception: Customer’s perception is crucial for any business. Medical Needs should listen to their customer’s plea and perception towards their services and work towards bettering the services according to the customer’s perception, (Ross, 2017).
To achieve quality gains, the managers need to perceive things in a different outlook. For any upcoming business, it will be necessary to perform these eight dimensions to ensure that their business picks up and moves to the next level. Medical Needs have a classified goal which is going to be achieved along implementation of the eight-dimensional model.
References
Chvala, R. J., & Johnson, W. C. (2017). Why Total Quality in Marketing. In Total Quality in Marketing (pp. 1-26). Routledge.
Garvin, D. (1987). Competing on the eight dimensions of quality. Harv. Bus. Rev., 101-109.
Ross, J. E. (2017). Total quality management: Text, cases, and readings. Routledge.
Medical Needs Quality Assurance Integration
Connie Farris
Colorado Technical University
Project Performance and Quality Assurance
(MPM357-1902A-02)
Jason Lewis
Running he.
0601017 explore market opportunities for new product launchSupa Buoy
This document is a project report submitted by Dnyanesh Prabhakar Joshi to the University of Pune in partial fulfillment of an MBA degree. The project involved exploring market opportunities for a new product launch by Resilient Cosmeceuticals Pvt. Ltd. in Pune, India. Joshi conducted primary research including surveys of doctors and chemists in Pune to analyze the market for anti-ulcer and anti-emetic drugs, and provide suggestions to Resilient Cosmeceuticals. The report includes an executive summary of the company, industry, and product being launched, as well as chapters describing the research methodology, findings of the surveys, and recommendations.
Shivaan Cooppan is a Production Pharmacist at Ranbaxy-Be-Tabs in Johannesburg, South Africa. He has held this position since July 2012, where he oversees the manufacturing of medications. Some of his accomplishments include successfully auditing for GMP compliance from 2012-2014, creating standard operating procedures and tracking systems, and reducing rejected batches due to process errors. Prior to his current role, Cooppan worked as a Community Service Pharmacist from June 2011-June 2012 and did a pharmacy internship from October 2010-January 2011 to complete his education and training.
This document provides a summary of the professional experience and qualifications of Dhiraj Kumar Chopra. It outlines his 20+ years of experience in the pharmaceutical industry, particularly in generic product development, parenteral formulations, and novel drug delivery systems. It also lists his employment history and achievements, as well as his education qualifications and publications.
Kanuri Prasad is seeking a career in quality assurance and regulatory affairs in the pharmaceutical manufacturing industry. He has over 4 years of experience in quality assurance at Vasudha Pharma Chem Limited, where he currently holds the role of Executive in the Corporate Quality Assurance department. His responsibilities include vendor qualification, change control reviews, complaint investigations, and preparation of regulatory documents like Drug Master Files. He holds a B.Pharmacy degree and has experience in process validation, cleaning validation, and internal auditing.
Similar a Software Used In Formulation Design Process- Minor Project [Bachelor].pdf (20)
Major Project (B. Pharm) OPIUM POPPY PROJECT.pdfRAHUL PAL
Opium cultivation, an ancient practice rooted in regions like the Golden Triangle and Golden Crescent, involves a meticulous process blending nature and human intervention. Picture a serene landscape with gently rolling hills blanketed in lush greenery. Amidst this verdant tapestry stand tall, slender opium poppy plants, their delicate petals shimmering in hues of pink and white. These plants exude an air of mystique, their bulbous seed pods containing the coveted opium latex. Skilled farmers nurture these plants with utmost care, tending to their needs for water, nutrients, and protection from pests. The cultivation cycle begins with sowing the poppy seeds during specific seasons conducive to their growth. As the plants mature, they blossom into exquisite flowers, each harboring the potential for opium production. The farmers deftly slit the seed pods at just the right moment, allowing the milky sap to seep out and gradually solidify into opium. This labor-intensive process demands precision and patience, as any misstep can impact the potency and quality of the opium yield. Despite its allure, opium cultivation is not without controversy and challenges. Legal restrictions, environmental concerns, and the socioeconomic impacts on communities underscore the complex nature of this age-old practice. However, for those entrenched in the art of opium cultivation, it remains a delicate dance between tradition, livelihood, and the ever-evolving dynamics of global demand and supply.
Niosomes are nanosized vesicles composed of nonionic surfactants and cholesterol that form when these compounds are dispersed in an aqueous medium. These lipid-based structures are similar to liposomes but differ in their composition, as niosomes use nonionic surfactants instead of phospholipids. The unique characteristic of niosomes lies in their ability to encapsulate both hydrophilic and hydrophobic drugs within their bilayer membrane. This feature makes them promising candidates for drug delivery systems, as they can protect the encapsulated drug from degradation, prolong its release, and enhance its bioavailability. Additionally, niosomes offer advantages such as biocompatibility, stability, and ease of preparation, making them a versatile platform for targeted drug delivery and other biomedical applications.
Niosome An Non-Ionic Surfactant Vesicles.pptxRAHUL PAL
Niosomes are novel drug delivery systems that have garnered significant interest in the pharmaceutical field. They are essentially vesicles composed of non-ionic surfactants and cholesterol, forming a bilayer structure similar to liposomes. However, unlike liposomes, which are composed of phospholipids, niosomes are formed by self-assembly of non-ionic surfactants in aqueous media. This unique composition offers several advantages such as improved drug solubility, stability, and biocompatibility.
The introduction of niosomes as drug carriers has revolutionized the field of drug delivery due to their ability to encapsulate both hydrophilic and hydrophobic drugs. This versatility allows for targeted and controlled release of therapeutics, enhancing their efficacy while minimizing side effects.
Moreover, the surface of niosomes can be modified to achieve specific targeting of drugs to desired sites within the body, thus enhancing therapeutic outcomes and reducing systemic toxicity.
Overall, niosomes hold great promise in the pharmaceutical industry and continue to be a subject of intense research for their potential applications in various fields including cancer therapy, gene delivery, and vaccine development.
𝐎𝐫𝐚𝐥 𝐏𝐚𝐩𝐞𝐫 𝐏𝐫𝐞𝐬𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧: 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 (𝐈𝐑𝐓𝐄𝐂 𝟐.𝟎-𝟐𝟎𝟐𝟒); The Curre...RAHUL PAL
Targeted drug delivery systems are employed to administer pharmaceutical medication,
facilitating the precise delivery of drugs to specific diseased areas. Several drug delivery
systems utilise carriers such as antibodies, transdermal patches, biodegradable polymers,
nanoparticles (NPs), liposomes, niosomes, and microspheres. Niosomes, on the other hand,
represent a promising and innovative category of vesicular systems. Niosomes are vesicles
formed by hydrating a combination of nonionic surfactants and cholesterol. These non-ionic
surfactant vesicles serve as carriers for both amphiphilic and lipophilic drugs. In the drug
delivery system using niosomes, the medication is enclosed within a vesicle. Niosomes in
tuberculosis (TB) possess biodegradable and biocompatible properties, are non-immunogenic,
and demonstrate versatility in their structural composition. It’s a serious and potentially deadly
infectious disease caused by a bacteria called Mycobacterium tuberculosis. In the recent
update, WHO still estimates 9.9 million new TB cases in 2022 at the latest. Involvement of
niosomes improves the treatment of TB with much more advanced technology and an advanced
drug nanocarrier with better treatment. The main highlights of this review paper are to
summarise the structure, compositions, preparation methods, and ICH stability guidelines for
the formulation of niosomes and their applications in TB with their several stages of treatment
by niosomal formulations.
Introduction: This study explores the use of Response Surface Methodology (RSM), a statistical optimization technique, to optimize the SR properties of prochlorperazine maleate (PCM) matrix tablets. PCM is a phenothiazine derivative used for treating schizophrenia, nausea, and vomiting. Sustained-release formulations offer extended drug delivery, potentially improving patient compliance and reducing side effects. RSM helps identify optimal combinations of critical formulation factors influencing drug release, such as polymer type and concentration, filler type, and drug/polymer ratio. The study likely involves designing experiments based on chosen RSM designs (e.g., Box-Behnken) with varying factor levels. Formulate SR tablets with different factor combinations. Evaluating the drug release profiles of each tablet formulation. Analyzing data using RSM software to build mathematical models relating factors to drug release and identifying optimal factor combinations that maximize desired release characteristics.
Objective: The ongoing research purpose to improve the advancement of a sustained release tablet containing Phenothiazine derivative PCM loaded matrix. This is achieved by utilizing DoE as a computational method to statistically validate the formulation.
THE CURRENT STATUS IN MUCOSAL DRUG DELIVERY SYSTEM (MDDS) AND FUTURE PROSPECT...RAHUL PAL
This systematic review aims to provide a comprehensive overview of the current status of
mucosal drug delivery systems (MDDS) and explore their future prospects in drug delivery.
MDDS have gained significant attention in recent years due to their potential to enhance drug
absorption, improve therapeutic efficacy, and minimize systemic side effects. This review
critically evaluates the existing literature on MDDS, including various mucosal routes such as
oral, nasal, ocular, pulmonary, and vaginal delivery. Additionally, it discusses the challenges
associated with MDDS, such as formulation development, stability, and regulatory
considerations. Furthermore, this review highlights emerging technologies and innovative
strategies that hold promise for the future of MDDS. Overall, this systematic review provides
valuable insights into the current landscape of MDDS and offers recommendations for future
research and development in this field.
Design of Experiments (DoE) manipulation in the formulation and optimization ...RAHUL PAL
Introduction: In India, the regulatory body for catechu is the Food Safety and Standards Authority of
India (FSSAI). The FSSAI is responsible for regulating the manufacture, sale, and distribution of food in
India, including catechu. The FSSAI has set standards for the purity and quality of catechu, and it also
monitors the market for adulterated catechu. The FDA (The Food and Drug Administration) is
responsible for regulating the safety and efficacy of drugs and dietary supplements in the United States
(US). The FDA has not approved catechu as a drug or dietary supplement, but it does regulate catechu as
a food additive. The FDA has set limits on the amount of catechu that can be added to food
Objective: The primary objective of this research was to involvement of design of experiments (DoE)
manipulation in the formulation and optimization of a traditional Ayurvedic medicine derived from dried
extract of Senegalia catechu enhanced through statistical analysis.
Methodology: The dried extract of Senegalia catechu was collected and identified at the botanical
herbarium garden. Subsequently, it underwent a drying process and was ground into a powder.
The Utilization of 32 Full Factorial Design (FFD) for Optimization of Linco...RAHUL PAL
Objectives: The ongoing research aims to enhance the development of LNH-loaded nanogel by
utilizing DoE as the computational method to statistically validate their formulation.
Methodology: In this research Chitosan used as a natural polymer and Poly (Ethylene glycol)
[PEG] as a penetration or permeation enhancer. The different nanogel of LNH were synthesized
using the Nanoprecipitation and Dispersion method, with variations in the drug-polymer ratio
(1/0.03, 1/0.08, 1/0.12). The process parameters were carefully optimizing for enhance the
efficiency of the synthesis. To achieve this, optimization studies were conducted using 3² FFD,
employing the Design Expert Software Trial version 10.0.7. The total of 13 runs were generated to
ensure comprehensive analysis and evaluation of the procedure. The selected independent
variables included the concentration of Chitosan (R1) and Carbopol 934 (R2). The dependent
variables, on the other hand, were particle size (P1), Polydispersity Index (P2), and % Drug release
(P3), chosen in that order. By employing this optimization technique, one can acquire valuable
information in a manner that is both efficient and cost-effective. This approach facilitates a deeper
comprehension of the relationship between controllable independent variables and the performance
and quality of the Nanogels being produced.
Determination of Partition coefficient of Known and Unknown drug.pdfRAHUL PAL
Partition coefficient, often denoted as P or P_oct, is a measure of how a solute distributes between two immiscible (unmixable) solvents. It is commonly used in chemistry, biochemistry, and pharmacology to understand the distribution of a compound between different phases, such as between a hydrophobic organic solvent and water. In experimental settings, the partition coefficient is determined by measuring the concentrations of the solute in each phase. The values obtained provide insights into the solute's behavior and can guide decisions in various scientific and industrial processes.
A pharmaceutical suspension is a heterogeneous system in which finely divided solid particles are dispersed in a liquid medium. Unlike solutions, where solutes are completely dissolved, suspensions involve particles that are only partially soluble or insoluble in the liquid. These suspensions are commonly used in the pharmaceutical industry to deliver medications that may be poorly soluble or unstable in their pure form. The solid particles, often in the form of powders or crystals, are dispersed throughout the liquid phase, creating a stable mixture through the use of suspending agents or stabilizers. These agents prevent the settling of particles, ensuring uniform distribution and ease of redispersion upon shaking before administration. Pharmaceutical suspensions offer advantages in terms of flexibility in dosing and formulation, enabling the delivery of therapeutic agents in various forms such as oral liquids, injectables, or topical preparations, enhancing patient compliance and therapeutic efficacy. The formulation and stability of pharmaceutical suspensions require careful consideration of factors such as particle size, density, and the choice of stabilizers to maintain a consistent and reliable product.
PHARMACEUTICAL SUPPOSITORIES & PESSARIES.pptRAHUL PAL
Suppositories and pessaries are both types of medication delivery systems that are designed to be inserted into body orifices for therapeutic purposes. While they serve similar functions, they are used in different parts of the body.
Suppositories:
Usage: Suppositories are typically designed for rectal or vaginal administration.
Composition: They are solid, bullet-shaped or cone-shaped dosage forms that contain medication in a base that melts or dissolves at body temperature.
Rectal Suppositories: Commonly used for medications that need to bypass the digestive system or when a patient cannot take medications orally. They are inserted into the rectum.
Vaginal Suppositories: Often used for localized treatment of gynecological conditions, such as yeast infections or hormonal therapy. They are inserted into the vagina.
Pessaries:
Usage: Pessaries are specifically designed for vaginal administration.
Composition: They are solid, oval-shaped or ring-shaped devices made of various materials such as silicone, rubber, or plastic.
Indications: Pessaries are mainly used to support the uterus, bladder, or rectum in cases of pelvic organ prolapse. However, they can also be used for the controlled release of medication into the vagina for the treatment of local conditions.
Maintenance: Pessaries need to be fitted by a healthcare professional and should be cleaned and reinserted regularly.
Partition Coefficient Determination (Pharmaceutics Practical).pptxRAHUL PAL
Partition coefficients are a fascinating and important concept in many fields, from chemistry and environmental science to medicine and pharmacology. They tell us about how a substance will distribute itself between two immiscible phases, like how a drug might move between your blood and tissues, or how a pollutant might spread through soil and water.
A partition coefficient, denoted as P or log P, describes the ratio of the concentration of a compound in one phase (usually organic) to its concentration in another phase (often water) at equilibrium.
Higher values of P indicate a greater preference for the organic phase, meaning the compound is more lipophilic (fat-loving).
Lower values of P suggest a higher affinity for the aqueous phase, implying the compound is more hydrophilic (water-loving).
Research Methodology_UNIT_V_Declaration of Helsinki M. Pharm (IIIrd Sem.)RAHUL PAL
Declaration of Helsinki: History, introduction, basic principles for all medical research, and additional principles for medical research combined with medical care.
The Utilization of Response Surface Methodology (RSM) In the Optimization of ...RAHUL PAL
The objective of the current studies to enhance the formulation of DS-loaded liposomes through the utilization of Response surface methodology (RSM) and involving the computation approach for their validation.
Investigational outcome represents the perceived responses were in related with the desired values and this represents the relationship of the RSM for optimization of % DR and % EE in DS loaded liposomal preparations.
Research Methodology (M. Pharm, IIIrd Sem.)_UNIT_IV_CPCSEA Guidelines for Lab...RAHUL PAL
CPCSEA guidelines for laboratory animal facility: Goals, veterinary care, quarantine,
surveillance, diagnosis, treatment and control of disease, personal
hygiene, location of animal facilities to laboratories, anesthesia, euthanasia, physical facilities, environment, animal husbandry, record keeping, SOPs, personnel and
training, transport of lab animals.
MEDICAL RESEARCH: UNIT_III_ EUTHANASIA, COI, CONFIDENTIALITY RESEARCH METHODO...RAHUL PAL
Medical research in clinical settings is the study of human health and disease in people. It is the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device, is safe and effective in people.
A clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.
Clinical trail is basically have 4 phases: Phase I, Phase II, Phase III, Phase IV
Biostatistics_Unit_II_Research Methodology & Biostatistics_M. Pharm (Pharmace...RAHUL PAL
This document provides an overview of biostatistics topics including parametric and non-parametric statistical tests, sample size calculation, and factors influencing sample size. It discusses commonly used parametric tests like the t-test, ANOVA, correlation coefficient, and regression analysis. Non-parametric tests like the Wilcoxon rank-sum test are also covered. The importance of considering sample size, factors that can impact it, and how dropouts are handled are summarized as well.
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptxRAHUL PAL
Research Methodology and Biostatistics syllabus:
Medical Research: History, values in medical ethics, autonomy, beneficence, non-maleficence, double effect, conflicts between autonomy.
Medical research has a long and varied history. It has evolved from rudimentary practices to sophisticated, evidence-based methodologies. Some key milestones include the development of the scientific method, the use of randomized controlled trials, the discovery of antibiotics, and the mapping of the human genome. Ethical concerns have also played a significant role in shaping the history of medical research, especially in response to various ethical violations, such as the Tuskegee Syphilis Study and the Nuremberg Trials.
Resolving conflicts between these principles often requires careful consideration, ethical analysis, and, in some cases, consultation with ethics committees or boards. The specific course of action may vary based on the individual circumstances and ethical frameworks employed by healthcare professionals and researchers. Ethical guidelines and regulations also play a significant role in addressing and preventing these conflicts in medical research.
Research Article Published: "Optimization and formulation of dox loaded lipos...RAHUL PAL
Doxorubicin (DOX) is a potent anticancer drug, but it is also associated with significant side effects, such as cardiotoxicity. Liposomal encapsulation of DOX can help to reduce these side effects and improve the drug's efficacy.
There are a number of different factors that can affect the optimization and formulation of DOX-loaded liposomes, including:
Lipid composition: The type and ratio of lipids used to form the liposomes can affect their size, stability, and drug encapsulation efficiency. Some commonly used lipids for DOX liposomes include hydrogenated soy phosphatidylcholine (HSPC), cholesterol, and distearoylphosphatidylglycerol (DSPG).
Drug loading method: There are a number of different methods for loading DOX into liposomes. Some common methods include the ammonium sulfate gradient method, the remote loading method, and the ethanol injection method. The choice of loading method can affect the drug encapsulation efficiency and stability of the liposomes.
Liposome size: The size of the liposomes can affect their circulation time in the body and their ability to target specific tissues. Smaller liposomes tend to have a longer circulation time and are better able to penetrate tumors.
Surface modification: Liposomes can be surface-modified with various ligands to improve their targeting and delivery properties. For example, liposomes can be conjugated with antibodies to target specific cancer cells.
The optimization of DOX-loaded liposomes is typically carried out using a quality by design (QbD) approach. QbD is a systematic approach to drug development that focuses on identifying and controlling the critical quality attributes (CQAs) of the drug product. The CQAs of DOX-loaded liposomes may include particle size, drug encapsulation efficiency, stability, and in vitro and in vivo performance.
Nucleic Acid Based Therapeutics Delivery.pdfRAHUL PAL
Nucleic acid-based therapeutics (NATs) are a promising new class of drugs that have the potential to treat a wide range of diseases, including cancer, genetic disorders, and infectious diseases. NATs work by directly targeting the genetic material of cells, either to alter gene expression or to repair damaged DNA or RNA.
However, delivering NATs to cells can be challenging. Nucleic acids are large and fragile molecules, and they can be easily degraded by enzymes in the body. Additionally, NATs need to be able to cross the cell membrane and enter the cytoplasm in order to function.
Nucleic acid-based therapeutics delivery is a rapidly evolving field, and new delivery systems are being developed all the time. As delivery systems improve, NATs are becoming more and more viable as treatments for a wide range of diseases.
This document provides an overview of wound healing, its functions, stages, mechanisms, factors affecting it, and complications.
A wound is a break in the integrity of the skin or tissues, which may be associated with disruption of the structure and function.
Healing is the body’s response to injury in an attempt to restore normal structure and functions.
Healing can occur in two ways: Regeneration and Repair
There are 4 phases of wound healing: hemostasis, inflammation, proliferation, and remodeling. This document also describes the mechanism of wound healing. Factors that affect healing include infection, uncontrolled diabetes, poor nutrition, age, anemia, the presence of foreign bodies, etc.
Complications of wound healing like infection, hyperpigmentation of scar, contractures, and keloid formation.
How to Make a Field Mandatory in Odoo 17Celine George
In Odoo, making a field required can be done through both Python code and XML views. When you set the required attribute to True in Python code, it makes the field required across all views where it's used. Conversely, when you set the required attribute in XML views, it makes the field required only in the context of that particular view.
A review of the growth of the Israel Genealogy Research Association Database Collection for the last 12 months. Our collection is now passed the 3 million mark and still growing. See which archives have contributed the most. See the different types of records we have, and which years have had records added. You can also see what we have for the future.
Strategies for Effective Upskilling is a presentation by Chinwendu Peace in a Your Skill Boost Masterclass organisation by the Excellence Foundation for South Sudan on 08th and 09th June 2024 from 1 PM to 3 PM on each day.
LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UPRAHUL
This Dissertation explores the particular circumstances of Mirzapur, a region located in the
core of India. Mirzapur, with its varied terrains and abundant biodiversity, offers an optimal
environment for investigating the changes in vegetation cover dynamics. Our study utilizes
advanced technologies such as GIS (Geographic Information Systems) and Remote sensing to
analyze the transformations that have taken place over the course of a decade.
The complex relationship between human activities and the environment has been the focus
of extensive research and worry. As the global community grapples with swift urbanization,
population expansion, and economic progress, the effects on natural ecosystems are becoming
more evident. A crucial element of this impact is the alteration of vegetation cover, which plays a
significant role in maintaining the ecological equilibrium of our planet.Land serves as the foundation for all human activities and provides the necessary materials for
these activities. As the most crucial natural resource, its utilization by humans results in different
'Land uses,' which are determined by both human activities and the physical characteristics of the
land.
The utilization of land is impacted by human needs and environmental factors. In countries
like India, rapid population growth and the emphasis on extensive resource exploitation can lead
to significant land degradation, adversely affecting the region's land cover.
Therefore, human intervention has significantly influenced land use patterns over many
centuries, evolving its structure over time and space. In the present era, these changes have
accelerated due to factors such as agriculture and urbanization. Information regarding land use and
cover is essential for various planning and management tasks related to the Earth's surface,
providing crucial environmental data for scientific, resource management, policy purposes, and
diverse human activities.
Accurate understanding of land use and cover is imperative for the development planning
of any area. Consequently, a wide range of professionals, including earth system scientists, land
and water managers, and urban planners, are interested in obtaining data on land use and cover
changes, conversion trends, and other related patterns. The spatial dimensions of land use and
cover support policymakers and scientists in making well-informed decisions, as alterations in
these patterns indicate shifts in economic and social conditions. Monitoring such changes with the
help of Advanced technologies like Remote Sensing and Geographic Information Systems is
crucial for coordinated efforts across different administrative levels. Advanced technologies like
Remote Sensing and Geographic Information Systems
9
Changes in vegetation cover refer to variations in the distribution, composition, and overall
structure of plant communities across different temporal and spatial scales. These changes can
occur natural.
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
Walmart Business+ and Spark Good for Nonprofits.pdfTechSoup
"Learn about all the ways Walmart supports nonprofit organizations.
You will hear from Liz Willett, the Head of Nonprofits, and hear about what Walmart is doing to help nonprofits, including Walmart Business and Spark Good. Walmart Business+ is a new offer for nonprofits that offers discounts and also streamlines nonprofits order and expense tracking, saving time and money.
The webinar may also give some examples on how nonprofits can best leverage Walmart Business+.
The event will cover the following::
Walmart Business + (https://business.walmart.com/plus) is a new shopping experience for nonprofits, schools, and local business customers that connects an exclusive online shopping experience to stores. Benefits include free delivery and shipping, a 'Spend Analytics” feature, special discounts, deals and tax-exempt shopping.
Special TechSoup offer for a free 180 days membership, and up to $150 in discounts on eligible orders.
Spark Good (walmart.com/sparkgood) is a charitable platform that enables nonprofits to receive donations directly from customers and associates.
Answers about how you can do more with Walmart!"
How to Fix the Import Error in the Odoo 17Celine George
An import error occurs when a program fails to import a module or library, disrupting its execution. In languages like Python, this issue arises when the specified module cannot be found or accessed, hindering the program's functionality. Resolving import errors is crucial for maintaining smooth software operation and uninterrupted development processes.
How to Manage Your Lost Opportunities in Odoo 17 CRMCeline George
Odoo 17 CRM allows us to track why we lose sales opportunities with "Lost Reasons." This helps analyze our sales process and identify areas for improvement. Here's how to configure lost reasons in Odoo 17 CRM
What is Digital Literacy? A guest blog from Andy McLaughlin, University of Ab...
Software Used In Formulation Design Process- Minor Project [Bachelor].pdf
1. SOFTWARE USED IN FORMULATION DESIGN PROCESS 1
SOFTWARE USED IN FORMULATION DESIGN PROCESS
A Project Report Submitted
In Partial Fulfillment of the Requirement
For the award of the Degree of
BACHELOR OF PHARMACY
Mr. RAHUL PAL
Enrollment No- 181091
Under the Supervision of
Ms. KARISHMA SINGH
DEPARTMENT OF PHARMACY
INVERTIS UNIVERSITY
INVERTIS VILLAGE, BAREILLY, UP.243123 INDIA
2021-2022
2. SOFTWARE USED IN FORMULATION DESIGN PROCESS 2
CERTIFICATE
I hereby certify that the work which is being presented in dissertation entitled
“SOFTWARE USED IN FORMULATION PROCESS”. Submitted Department of
Pharmacy, Invertis University, Bareilly in the fulfillment of the requirement for the
award of degree of Bachelor of Pharmacy in drug design embodies the original research
work carried out by RAHUL PAL. This work has been completed under my
supervision and guidance. This is further stated that no part of this dissertation has been
submitted previously either in part or full, for the award of any degree to this or any
other university.
Supervisor Head of Department
Ms. Karishma Singh Mrs. Surabhi Sharma
Associate Professor (HEAD OF DEPARTEMENT)
Department of Pharmacy Department of Pharmacy
Date:………….
DEPARTMENT OF PHARMACY,
INVERTIS UNIVERSITY, BAREILLY
3. SOFTWARE USED IN FORMULATION DESIGN PROCESS 3
DECLARATION BY THE CANDIDATE
I, RAHUL PAL, here by, declare that the present work entitled “SOFTWARE USED IN
FORMULATION DESIGN PROCESS” And is based on the research work carried out by me under the
supervision of Ms. Karishma Singh in partial fulfillment of the requirement for the award of degree of
Bachelor of Pharmacy from DEPARTEMENT OF PHARMACY, INVERTIS UNIVERSITY,
BAREILLY, during the Academic year 2021-2022.
It is further stated that no part of this project work has been submitted previously either in part or full, for
the award of any other degree by me, to this or any other university.
Place: Bareilly RAHUL PAL
Date…………. Enrollment no.181091
Roll No. 1810601006
4. SOFTWARE USED IN FORMULATION DESIGN PROCESS 4
This is to certify that Mr. Rahul Pal has completed his completed his project of the degree of Bachelor of
Pharmacy on the topic “Software Used in Formulation Design Process”. I further certify that the work
done by him is of his own and original and tends of the general advancement of knowledge. The work was
carried out under my supervision and guidance at, Department of Pharmacy, Invertis University, Bareilly
during the academic year 2021-2022. This work is up to my satisfaction.
Head of Department External Examiner Mrs. Surabhi
Sharma
Department of Pharmacy
Invertis University, Bareilly
Date…………….
5. SOFTWARE USED IN FORMULATION DESIGN PROCESS 5
ACKNOWLEDGEMENT
Coming up with an idea is not difficult for anybody, but giving it a start and taking it to the
completion is a different story all together. So here I am bound to be grateful to the numerous
people who made it possible for me to give shape to the idea which I considered as my project.
I’m RAHUL PAL feel immense pleasure in praising the almighty for his grace, guidance,
strength and blessing showered on me to complete this project work as a part of B. Pharm.
Curricula at the “Department of Pharmacy, Invertis Village, Invertis University, Bareilly.
I am extremely thankful to Ms. Karishma Singh was always there to help me in solving my
problems, sharing fruitful discussion, supportive cooperation and affectionate behaviors during
my project period. And I would also like to say thanks to all teaching and non-teaching staff of
Department of Pharmacy, Invertis University, Bareilly for providing me some common help
during my project time.
I take pride in acknowledging the solicitous help and concern of who have given their effort in
guiding me in achieving my goal as well as their encouragement to maintain my progress on
track.
I take this golden opportunity to express my heartfelt thanks to my friends who remained
constantly a source of inspiration in hard time during the course. Finally, my efforts will remain
incomplete, if I fail to acknowledge the support of my family, in giving me love, care and moral
support that I need in life.
They were always ready to extend all possible help which give me great encouragement. What I
am today is because of love, care, support and all blessing of my family members.
Thanks to all for what I am today
Date: -_____
6. SOFTWARE USED IN FORMULATION DESIGN PROCESS 6
CONTENT
PAGE NO.
Design of Software 01
Parsimony Principle 01
Design of Experiment for Formulation and Development 01
Pharmaceutical Formulations 02
Drug 02
Methods 03
Preformulation study 03
Process feasibility 03
Design of experiment 03
Evaluation of formulation 04
Tools for drug release & Pharmacokinetics study. 04
Drug Discovery Software 05
Introduction 05
Drug Design Process 06
- Ligand Based Drug Design. 07
- Structure Based Drug Design 08
Computer aided drug formulations 09
Computer software 10
Software for Drug Designing, Formulation and Development 11
CADD 12
Computer Aided Software 13
MapCheck 13
Schrodinger 14
ArgusLab 15
Discovery Studio Visualizer 16
QSARPro 17
MARS (Multimodal Animal Rotation System) 18
How to used Design Expert Software Version 7.0 19
SOP of Design Expert Software 19
ChemDraw 20
- Chem3Dand ChemFinder 21
- Feature of ChemDraw 21
Other Methods Involving 22
- SwissADME 23
- Pharmacokinetics 24
- Medicinal chemistry 25
Conclusion 26
References. 27
7. SOFTWARE USED IN FORMULATION DESIGN PROCESS 7
DESIGN OF EXPERIMENTS
“Is a structure organized method used to determine the factor affecting to process and
output of that process.”
Parsimony Principle:
Some of factor are important, while another factor is not important.
Few variables are effective or other are not effective.
Experiment design is an integral part of optimization technique.
Those technique used in the formulation optimization.
Design of Experiment for Formulation and
Development: All pharmaceutical products are formulated to specific
dosage from drugs to be effectively delivered to patient typical pharmaceutical dosage
from include tablets, capsules, solution & suspension etc. [07]
i. Different dosage form required different technology usually present
different technological challenges for formulation & development.
ii. Due to complex challenges, formulation scientist used effective
methodology like as experiment and statistical analysis for formulation
and development.
Formulation scientist used this method for process optimization and processvalidation.
Formulation and Development are a process of selection of components and
processing.
Now days computer tools used in the formulation and development of pharmaceutical
products.
Pharmaceutical product is formulated to specific dosage forms for drugs to be
effectively delivered to patient.
8. SOFTWARE USED IN FORMULATION DESIGN PROCESS 8
Pharmaceutical Formulation:
In pharmaceutics, is the process in which different chemical substances, including the
active drug, are combined to produce a final medicinal product. The word
formulation often used in a way that includes dosage form.
Today, computers are so ubiquitous in pharmaceutical research and development that it
may be hard to imagine a time when there were no computers to assist the medicinal
chemist or biologist.[08]
Computers began to be utilized at pharmaceutical companies as early as the 1940s.
DRUG
Any substance is important to impart or give the therapeutic activity is known as
Drug.
Drug is important to give pharmacological response and it act has target site of infection
and prevent injury or disease and disorder; drug was administered in various route of
administration depending on their types.
Definition: - “A drug defined as any substance or group of substance which
affect living tissue.
OR
“It is defined as any substance used to prevent, diagnosis or treat disease or to prevent
pregnancy”.
Examples of Drugs-
Anti-hemorrhoid drugs, topical antibiotics, cough suppressants, anti-acne drugs, non-
steroidal anti-inflammatory drugs, antiseptics, analgesics, anesthetic, anthelmintics,
antipyretic, antidotes, anti-infective, anticonvulsants, antibiotics, antidiarrheics,
antitussive, androgens, salicylates, vasodilator, antacids, expectorants, anti-fungal
drugs, anti-histamines, antigas agents and smoking cessation drugs and also many
more including these.
9. SOFTWARE USED IN FORMULATION DESIGN PROCESS 9
Preformulation
Process Feasibility
Design of
Experiment/
Evaluation
Methods
A). Preformulation Study: Important step for determination of physiochemical
properties of all the material before incorporating it in formulationdevelopment.
Preformulation studies are indispensable protocol for development of safe, effective and
stable dosage form.
B). Process Feasibility: Study to determine whether the manufacturing
process selected is capable to process the formulation.
C). Design of Experiment: DOE allows to evaluate multiple factors and their
interactions while fully controlling the number of experiments.
Design of Experiment (Design Expert Software 10.0)
“Design-Expert provides powerful tools to lay out an ideal experiment on your process,
mixture or combination of factors and components. Design-Expert’s design wizards and
intuitive layouts such as the stoplight configuration for two-level factorials make it all
far easier than you’d even imagine.”
10. SOFTWARE USED IN FORMULATION DESIGN PROCESS 10
Such techniques are usually referred to as ‘Computer-Aided Dosage from
Design’ (CADD).
D). Evaluation of Formulation This parameter include:
% Yield.
Drug entrapment efficiency and Drug Loading.
Drug Excipients Compatibility study.
FT-IR study.
DSC Study.
XRD Analysis.
Morphological Characterization.
Particle size and zeta potential Analysis.
SEM & TEM Analysis.
Drug Release Study.
Drug Release Kinetics & Pharmacokinetics Study.
Stability Study.
Tools for Drug Release & Pharmacokinetic Study
USP Dissolution Test Apparatus
High Performance Liquid Chromatography (HPLC).
High Performance Thin Layer Chromatography (HPTLC).
11. SOFTWARE USED IN FORMULATION DESIGN PROCESS 11
INTORDUCTION: Drug discovery software is used to develop new
DRUG DISCOVERY SOFTWARE
pharmaceutical drugs and test whether a newly created drug will be effective in treating
a particular disease. Drug discovery software automates and leverages innovative
technology that significantly cuts down on the arduous process of drug development,
testing, and going to market.[10]
Most drug discovery solutions offer screening, predictive analytics, modeling, simulation,
and computational capabilities.
Researchers and scientists use drug discovery software to gain market intelligence, take
advantage of advancements in drug design and synthesis, tackle evolving and adapting
diseases, and maintain and manage the integrity of data as drugs transition from the
discovery phase to the clinical trial phase.
Computer aided drug design uses computational chemistry to discover enhance or study
drugs and related biologically active molecules. Software based drug discovery and
development methods have major role in the development of bioactive compounds for over
last three decades.
Computer- assist drug design (CADD), also called Computer assist molecular
design (CAMD), and represent more recent applications of computer as tools in the drug
design process and many new software used in modern days, and in the fields of
biochemistry, molecular biology, and cell biology, facilitated by development in
genomics and proteomics, are producing a large number of novel biological targets that
may be exploited för therapeutic intervention. [04]
The latest technological advances (QSAR, QSPR, Structure-based design,
Ligand Based Design, Combinatorial library design, Cheminformatics &
Bioinformatics).
12. SOFTWARE USED IN FORMULATION DESIGN PROCESS 12
DRUG DESIGN PROCESS
It is the inventive process of finding new medications based on the knowledge of a
biological target.
It involves the design of molecules that are complementary in shape and charge to the
biomolecular target with which they interact and therefore will bind to it.[02]
Selected/Designed molecule should be-
Organic small molecules/ Complementary in shape to the target.
Oppositely charge to the biomolecules target.
This molecule will-
Interact with target/Bind to the target.
Activates or inhibits the function of a biomolecules such as a protein.
This type of modeling is sometimes referred to as Computer-aided drug design.
13. SOFTWARE USED IN FORMULATION DESIGN PROCESS 13
LIGAND-BASED DRUG DESIGN: - Target site is
known. These ligands can be used to developed a pharmacophore model or molecule which
In LBDD, 3D structure of the target protein is not known possesses
all necessary structural features for bind to a but the knowledge of ligands which binds to
the desired target active site. [01]
Figure for Outline of process involved in LBDD
Ligand based drug design is an approach used in the absence of the receptor 2D
information and it relies on knowledge of molecules that bind to the biological target of
interest. 3D quantitative structure activity relationship (3D QSAR) and pharmacophore
modeling are the most important and widely used tools in ligand-based drug design.
They can provide predictive models suitable for lead identification and optimization.
Further information on these methods and their applications to 5-LOX inhibitor design
and development are presented elsewhere in the reviews.
14. SOFTWARE USED IN FORMULATION DESIGN PROCESS 14
STRUCTURE-BASED DRUG DESIGN
Structure based drug design (or direct drug design) relies on knowledge of the three-
dimensional structure of the biological target obtained through methods such as x- ray
crystallography or NMR spectroscopy.
If experimental structure is not available. Within many of the rational drug design
projects in the group, computer-aided methods, such as virtual screening and de novo
design techniques, play an important role in follows 3-D structure three- dimensional
structure of compound can generated and studies using molecular modeling software
package such as Chem3D. [01-02]]
The 2-D structure is converted into a 3-D structure is converted into 3-D structure, which
is quite clever, but is not error free, since the structure created is usually distorted (the
bond lengths and the bond angles are not ideal).
15. SOFTWARE USED IN FORMULATION DESIGN PROCESS 15
Reducing
cost
Safety &
Reducin
g Error
Optimization
Saving
time
Saving
money
COMPUTER AIDED DRUG FORMULATION
Formulation and development are a process of selection of components and processing.
Now days computer tools used in the formulation and development of pharmaceutical
products.
- Various techniques, such as design of experiment are implemented for
optimization of formulation and processing parameter.[02]
- Traditionally optimization in pharmaceuticals refer changing one variable at a
one time, so to obtain solution of a problematic formulation.
Many times, finding the correct answer is not simple and straight forward in such cases
use of computer tools (Optimization procedure) for best compromise is the smarter way
to solve problem.
Optimization means- Optimization means choosing the best element from some set of
available alternatives.
16. SOFTWARE USED IN FORMULATION DESIGN PROCESS 16
COMPUTER SOFTWARE- There are several software which
are used in the formulation process, mainly given below and some of their feature also
include in: - [09]
Software Silent Feature
Design Expert Powerful & compressive package used for
optimizing pharmaceutical formulation andprocess.
Minitab Powerful DOE software for automated data analysis
data analysis MS-Excel compatibility. Include
almost all design of RSM.
DOE PRO XL MS-Excel compatible DOE software for automated
data analysis.
CARD Powerful DOE software for data analysis includes
graphics and help feature.
17. SOFTWARE USED IN FORMULATION DESIGN PROCESS 17
Software for Drug Designing, Formulation and
Development
The software is further categorized on the basis of task performing by the software and
their working principle like software assessing pharmacokinetics parameters, ligand
interaction and molecular dynamic, molecular modelling and structural activity
relationship, image analysis, visualizers, data analyzer and behavior analysis
software etc. [03-04]
Sr.
No.
Pharmacological
Activity
Software Name Major Uses
01. Pharmacokinetics
Parameters
DDDPlus
MapCheck
-Dissolution and disintegration study.
-Compare dose or fluency measurement.
02. Ligand Interactions &
Molecular Dynamic
Autodock
Schrodinger
GOLD
BioSuite
-Evaluate the ligand-protein interaction
-ligand receptor docking
-Protein-ligand docking
-Genome analyzing & sequence analysis
03. Molecular modeling &
Structural Activity
Relationship
Maestro
ArgusLab
Sanjeevini
PASS
-Molecular modeling analysis
-Molecular docking calculation and molecular
modeling package.
-Predict protein-ligand binding affinity
-Create and analysis of SAR Model.
04. Image analysis and
Visualizers
AMIDE (A Medical
Image Data Examiner)
Discovery Studio®
Visualizer
Imaging Software Scge-
Pro
-Medical image analysis in molecular
imaging.
-Viewing and analyzing protein data.
-Cytogenetic & DNA damage analysis.
05. Data analysis QSARPro
REST 2009 Software
-Protein-Protein interaction study.
-analysis of gene expression data.
06. Behavior study Ethowatcher
MARS (Multimodal
Animal Rational System)
-Behavior analysis.
-Animal activity tracking, enzyme activity,
nanoparticle tracking and delivery study.
These all the highlights software commonly used software used for new drug development
along their potential uses.
18. SOFTWARE USED IN FORMULATION DESIGN PROCESS 18
Drug
candidate
CADD (Computer Aided Drug Design)
Drug design is a lengthy process that takes around 10-15 years and costs up to
2.558 billion USD för a drug to reach the market. Computer aided drug design (CADD)
method is widely CADD consist use of any software program based used as a new drug
design approach. It has been seen process for establishing a standard to relate activity to
that by the use of CADD approaches we can reduce the structure.
Figure 2:General Principle for Drug design through CADD.
Major types of approaches in CADD
There are mainly two types of approaches for drug design through CADD isthefollowing:
1. Structure based Drug Design / Direct Approach
2. Ligandbased Drug Design / Indirect Approach
CADD
Structure Based
drug design
Binding site
identification
Docking and
scoring
Pharmacophore
modelling
Virtual
Screening
ligand based
drug design
Quantitative structure
activity relationship
Lead Optimization
New Drug
It is a multistep process that begins with the identification of suitable drug target,
validation of drug target, hit to lead discovery, optimization of lead molecules, and
preclinical and clinical studies.
Compound Selection
19. SOFTWARE USED IN FORMULATION DESIGN PROCESS 19
The use of computer aided drug design (CADD) techniques in preliminary studies by
leading pharmaceutical companies and research groups has helped to expedite the drug
discovery and development process minimizing the cost and thefailures in the final stage.
This revies article provides useful insight into some of the common in silico methods used
in CADD and how these methods have been currently used and can be of help in the
drug discovery process of COVID-19 as well as other drug molecules.
Other Update Versions of DE-
History: - Stat-Ease Company released its version of DE in 1998.
In 1996 the fil released version 5 which was the first version of the
software-
DE Version 6.0
DE Version 7.0
DE Version 8.0
DE Version 9.0
DE Version 10.0.7
Latest Version of DE Software – 11
Computer Aided Software:
Design-Expert ® 7.0.0. Software.
Design-Expert® 10.0.0. Software.
MapCheck: The MapCheck compare absolute dose measurements of both
systems with ion chamber results. It compares IMRT QA process of Sunnuclear’s
MapCheck and Varian’s Portal Dosimetry. The MapCheck system create verification
plan for each field, export calculated dose map (Frontal) to MapCheck for each field,
calibrated diode array prior to collecting data. Standard deviation increases with plan
complexity. [05-06]
The average measured dose is independent of plan complexity.
Use. - MapCheck used for IMRT verification. - Small detectors identify MLC. -
Dose based EPID IMRT QA done by using MapCheck.
20. SOFTWARE USED IN FORMULATION DESIGN PROCESS 20
Schrodinger: Schrodinger software has wide range of applications that can solve
most of the challenges these bio-molecules will bring. It highlights particular advances in
molecular modeling, molecular dynamics, ligand-receptor docking, and biologics that were
designed to handle these challenges. [ 05-06]
Structure based properties of molecule such as understanding of conformational changes and
hydrophobicity of structures can be analyzed by this software.
This intern provides information atomic movements of macrocycles that further used to
understand shape, stability, and energetics. Schrodinger provides powerful and intuitive graphical
interfaces for system setup, running simulations, and analyzing trajectories.
The molecular dynamics simulations software is employed to study a series of stabilized
stapled α-helical peptides at different temperatures.
Use. - Molecular dynamics simulation studies - Quantum mechanics - Prediction of binding
affinity.
21. SOFTWARE USED IN FORMULATION DESIGN PROCESS 21
ArgusLab
ArgusLab is a molecular modeling, graphics, and drug design program for Windows
operating systems. [05-06] Conformational analysis such as P.G. Jamkhande et al.
Bulletin of Faculty of Pharmacy, Cairo University 55 (2017) 203–210 206 geometry
optimization study was performed on a window-based computer using ArgusLab.
This software works on the principle of quantum mechanics and helps to predict potential
energies, molecular structures, geometry optimization of structure, vibration frequencies
of coordinates of atoms, bond length, bond angle and reactions pathway. ArgusLab
calculate minimum potential energy using geometry convergence function.
Use. - Molecular docking calculations. - It is used to build molecules. - Building of
molecules using template structure. - For molecular modeling Package.
23. SOFTWARE USED IN FORMULATION DESIGN PROCESS 23
QSARPro: - This software identifies of relationship of a molecular activity or
property with the structural parameters, analysis of such relationships and rapid
predictions using reliable statistical modeling.
It is employed to evaluate more than 1000 molecular descriptors including
physicochemical, topological and electro-topological, information theory based,
quantum mechanical, electrostatic and hydrophobic, alignment independent, MMFF
atom types and so on. [05-06]
QSAR modeling typically involve activities such as descriptor choice and calculation,
statistical evaluation of the calculated descriptors, training and test set assignment,
regression and results analysis.
It evaluates multiple options for classes of descriptors, test set, choice of linear or nonlinear
regression and choice of regression technique to determine the option that is most suitable
to a particular project.
Use. - Explore and exercise various combinations of variable selection methods and
regression methods. - Aligning given set of molecules in the protein active site with
respect to the co-crystal ligand to develop a basis for the placement of ligand. - Protein-
protein interaction studies
24. SOFTWARE USED IN FORMULATION DESIGN PROCESS 24
MARS (Multimodal Animal Rotation System)
MARS is a Multimodal Animal Rotation System which captures 360° movement of an
experimental animal. The software is designed in such a way that it automatically
rotates a mouse to the required positions or angels to track all the relevant molecular
and anatomical information of experimental animal. It also captures optical signals
generated due to orientation of experimental. Using this software automatic co-
registration and capturing of multimodal and multispectral data sets from all acquired
angles is possible. [05]
The software amplifies obtained signal sensitivity by quantifying the perfect image or
exporting complete rotation movements or video. This software includes animal rotation
device, controlling software, and multimodal visualization and co- registration software.
Use. - Cell tracking. - Enzyme activity. - Bone disease. - Inflammatory disease. -
Nanoparticle tracking and delivery.
25. SOFTWARE USED IN FORMULATION DESIGN PROCESS 25
How to used Design Expert Software Version 7.0:
www.statease.com
How to install design expert software [11.]-
01. Install the exe file.
02. Do not run design expert now.
03. Copy the crack from crack folder to C/program file/DX 7 trail run.
04. If you want help then press F1 for help.
SOP of Design Expert Software
01). File new design.
02). Click response surface.
03). Add numeric factor.
04). Write name of independent variable. 05).
Add lo limit and high limit.
06). Continue.
07). Add response/ Run will be generated.
26. SOFTWARE USED IN FORMULATION DESIGN PROCESS 26
ChemDraw
ChemDraw is a molecule editor first developed in 1985 by David A. Evans and
Stewart Rubenstein (later by the cheminformatics company Cambridge Soft). The
company was sold to PerkinElmer in the year 2011. ChemDraw, along with Chem3D
and ChemFinder, is the part of the ChemOffice suite of programs and is available and is
available for Macintosh and Microsoft Windows. A simplified, touch optimized
version for the iPad was released in late 2013. [13]
The drawing of chemical formulae and reaction schemes is a repetitive task for
chemical on all levels of their education. While hand sketching is most efficiency used
during discussions and learning, neat drawing is required for official reports, publications
& theses.
- Such drawing can be created with several computer programs and one
example is ChemDraw.[13]
ChemDraw is a simple-to-use program that allows to draw intuitively and efficiently
simple two-dimensional representation of organic molecules. It is available for the
PC as well as for the Mac platform.
27. SOFTWARE USED IN FORMULATION DESIGN PROCESS 27
Chem 3D- Modeling 3D compounds, import structure from large database,
interconvertible with ChemDraw.
ChemFinder- Transfer files into tables for search, import structure data.
Feature of ChemDraw: ChemDraw is a chemistry software which
helps us in many chemical structures. There main properties discussedbelow: -[12]
01. Chemical structure to name conversion.
02. Chemical name to structure conversion.
03. NMR spectrum simulation.
04. Mass spectrum simulation.
05. Structure cleanup.
06. An extensive collection of templates, including style templates for most major
chemical journals.
07. Export to SVG (Window version only).
08. Export the structure into PDF (Mac version only).
09. It can give the properties of saturation and unsaturation.
10. It is very useful.
28. SOFTWARE USED IN FORMULATION DESIGN PROCESS 28
OTHER METHODS INVOLVING
SwissADME-
There website allows us to compute physiochemical descriptors as well as predict
ADME parameters. Pharmacokinetics properties. Drug like nature and medicinal
chemistry friendliness of one or multiple small molecules to support drug discovery
- The main article describing the web service and its underlying methodologies is
SwissADME: A free web tool to evaluate pharmacokinetics. Drug-likeness and
medicinal chemistry friendliness of small molecule. Scl Rep. (2017).
- Developed and maintained by the molecular modeling group of the SIB.
Swiss institute of Bioinformatics. [06]
This allows experts and as well as nonexpert to make use of the website for their
research. SwissADME was made for application in drug discovery and medicinal
chemistry contexts, which stresses for a balance between accuracy and speed in order to
deal with a large number of molecules.
Drug development involves assessment of absorption, distribution, metabolism and
excretion (ADME) increasingly earlier in the discovery process, at a stage when
considered compounds are numerous but access to the physical samples is limited.
Easy efficient input and interpretation are ensured thanks to a user-friendly interface
through the login-free website http://www.swissadme.ch. Specialists, but also nonexpert
in cheminformation or computational chemistry can predict rapidly key parameters for a
collection to molecules to support their drug discovery endeavours.
29. SOFTWARE USED IN FORMULATION DESIGN PROCESS 29
01). SwissADME: SwissADME software (www.swissadme.ch. ) of Swiss institute
of bioinformatics (http://www.sib.swiss ) was accessed a web server that displays the
submission page of SwissADME in google was use to estimate individual ADME
behaviors of the compounds from the plant. The input zone itself contains a molecular
sketcher based on Chem Axons Marvin JS (http://chemaxon.com ) that allows the user to
draw and edit 2D chemical structures.
- The structure transferred as a list to the right-hand side of the submission page, is the
actual input for computation. [06] The list is made to contain one input molecule per line
with several inputs, defined by Simplified Molecular Input Line Entry System
(SMILES) the results are presented for each molecule in tables, graphs and also an
excel spreadsheet.
30. SOFTWARE USED IN FORMULATION DESIGN PROCESS 30
06). Pharmacokinetics:
Pharmacokinetics is the quantitative study of the drug movement in, through and out of
the body. Intensity of effect is related to concentration of the drug at the site of action,
which depends on its pharmacokinetics properties. Pharmacokinetics properties of
particular drug is important to determine the route of administration, dose, onset of
action, peak action time, duration of action and frequency of dosing.Show in figure14
A simple definition of pharmacokinetics is the study of the course of drugs concentration
in the body (what the body does to the drug).
The role of pharmacokinetics (PK) in drug discovery is to support the optimization
of the absorption, distribution, metabolism and excretion (ADME) properties of lead
compounds with the ultimate goal.
31. SOFTWARE USED IN FORMULATION DESIGN PROCESS 31
07). Medicinal Chemistry: The role of the medicinal chemist in drug discovery
has undergone major changes in the past 24 years, mainly because of the introduction of
technologies such as combinatorial chemistry and structure-based drug design.
Medicinal chemistry plays a crucial role in driving the drug discovery project by relying on
their knowledge and expertise in modern organic chemistry, biology of the disease. Show
in Image [13].
In vitro screens for pharmacokinetics properties, the focus on synthesizing drug-like
compounds, and in Vitro Toxicity screens are important new developments that aid the
medicinal chemist’s job today.
One of the fundamental aspects of CADD activity is to select the most promising virtual
molecules submitting to biological assay.
Main Content Include in Medicinal
Chemistry
QSAR, Molecular Docking & Pharmacophore Modelling.
32. SOFTWARE USED IN FORMULATION DESIGN PROCESS 32
CONCLUSION:
We have discussed different software based on different approaches that are playing
major role in the drug designing and drug discovery now days. Successful
implementation of software-based techniques provided an opportunity for the in vitro
identification of biologically active agents, without bias towards known hits orleads.[13]
Using design of experiment formulation scientist evaluate the all-formulation factors in
systematically and timely manner to optimize the formulation and manufacturing
process. When the pharmaceutical process and product are optimized by systematic
approach then process validation & scale up can be efficient because of the robustness of
the formulation and manufacturing process. Design of experiment & statistical analysis
have been used in the formulationdevelopment.
Computer aided drug design is an efficient tool in the area of drug discovery and
development, through it we can find the most promising drug candidate in a very cost-
effective way. It always provides a hope for betterment in drug discovery area, With the
current achievement’s, there is a promising future of computer aided drug design to aid
drug discovery of many more curatives in future. [14]
The computer aided drug design has large number of success stories and continue to
play a vital role in the drug discovery process. In this regard, the approach has been
utilized in proposing drug candidate against coronavirus disease 2019 (COVID-19).
33. SOFTWARE USED IN FORMULATION DESIGN PROCESS 33
REFERENCES:
01). JAIN N K “Pharmaceutical Product Development”, CBS Publisher; New
Delhi 2010. Pp 295-340.
02). Ganesh R. GODAGE Advance Drug Delivery System, Tech Max Publication
Pune 2017. Pp 6.1-6.24.
03). Bolton S. Bon C, Pharmaceutical Statistic Practical & Clinical Application, 5th
ED, New York London; INFORMA Healthcare Publishing: 2010. Pg. No 239.
04). Aguilar JE (Eds). Formulation Tools for Pharmaceutical Development, PA:
Elsevier/Philadelphia, 2013.
05). https://www.slideshare.net/RonakkB17/computer-aided-formulation-and-
developmenthow-to-use-design-expert-software
06). https://www.slideshare.net/RonakkB17/computer-aided-formulation-design- expert-
software-case-study.
07) https://www.slideshare.net/prkppt/pharmaceutical-emulsionemulsion
08). Bernard D, Coop A, MacKerell A D Jr. Computer-Aided Drug Design:
Structure-Activity Relationships of Delta Opioid Ligands. Drug Design Reviews.
2005;2: 277-291.
09). Lachman LH, Lieberman, Kanig JL. The Theory and Practice of Industrial
Pharmacy, Lea & Febiger, 3rd edition, 1986.
10). www.wikipedia.org
11). www.statase.com
12). Husaain AS, Shivanand P, Johnson Rd. Application of Neural Formulation
Design, Drug Development and Industrial Pharmacy- 1994 Jan 1;20(10): 1739-52.
13). Nature.com/article/nrd1523; “The role of the medicinal chemistry in drug
discovery- then and now.”
14). https://www.google.com/amp/s/slideplayer.com/amp/7724755/
15). Kapetanovic IM. Computer-aided drug discovery and development (CADD):
insilico-chemico-biological approach. Chemico-biological interactions. 2008;
171(2):165-76.